Clinical Trials Project Manager and Regulatory Assistant
Clinical Project Manager and Regulatory Assistant
San Diego, CA - On- Site
$105,000 - $140,000
A clinical-stage biotech company in San Diego is seeking a Clinical Development Operations Lead to manage global clinical trials and support regulatory strategy across a diverse pipeline. This role is ideal for someone with a strong foundation in clinical research, regulatory coordination, and cross-functional leadership.
Key Responsibilities
- Clinical Trial Oversight: Lead the planning, execution, and closeout of global clinical studies, ensuring alignment with development and regulatory goals.
- Protocol & Site Management: Contribute to protocol design, site selection, and ongoing site relationships.
- Regulatory Support: Assist in the preparation of regulatory documents (e.g., INDs, briefing books, investigator brochures) and support health authority interactions.
- Cross-Functional Collaboration: Partner with internal teams across clinical operations, data management, medical affairs, and external vendors.
- Scientific Contribution: Review clinical data, support interpretation of results, and contribute to publications and presentations.
- Process Optimization: Participate in internal process improvement initiatives and mentor junior team members.
- Budget & Vendor Management: Develop and manage clinical trial budgets and oversee CROs and other external partners.
Qualifications
- Advanced degree in life sciences (PharmD, PhD, MS preferred).
- 5-7 years of clinical development experience in biotech or pharmaceutical settings.
- Proven track record in IND submissions and regulatory interactions.
- Experience in rare diseases, metabolic, CNS, or liver/kidney indications preferred.
- Familiarity with RNA-based platforms (siRNA, ASO) is a plus.
- Strong project management, communication, and leadership skills.
- Ability to work across time zones and manage international teams
This role offers the opportunity to contribute to groundbreaking therapies in a dynamic and innovative environment. If you are passionate about clinical operations and making a difference in patients' lives, we encourage you to apply.
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